Regulatory Affairs Specialist

3w3 weeks ago

Medtronic

Jakarta, ID · Full-time

About this role

At Medtronic, you can begin a life-long career of exploration and innovation while championing healthcare access and equity. As a Regulatory Affairs Specialist, you will drive product registrations, maintain licenses, and ensure ongoing post-market regulatory compliance to guarantee patient access to life-saving medical devices.

This role directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company. You will lead the compilation of materials required for submissions, license renewal, and annual registrations while monitoring and improving tracking and control systems.

You will serve as a critical bridge between local commercial teams and regional regulatory bodies to ensure timely patient access. The position also recommends changes for labeling, manufacturing, marketing, and clinical protocol to maintain regulatory compliance, and you will keep abreast of regulatory procedures and changes.

You will join a global team of over 95,000 passionate people united by a mission to alleviate pain, restore health, and extend life. Medtronic offers a competitive Salary and flexible Benefits Package, including eligibility for the Medtronic Incentive Plan (MIP).

Requirements

Minimum 4 years of relevant experience in regulatory affairs within the medical device or healthcare industry.
Working knowledge of regulatory requirements and submission processes.
Experience supporting product registrations, renewals, and compliance activities.
Strong organizational and documentation skills.
Ability to manage multiple projects and timelines effectively.
Excellent English communication skills, with the ability to collaborate across teams.

Responsibilities

Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.

Benefits

Eligibility for the Medtronic Incentive Plan (MIP).
Flexible benefits package.
Wide range of benefits and resources designed to support you at every career and life stage.